Reiki/Energy Healing in Prostate Cancer

• ClinicalTrials.gov Identifier: NCT00065208
• Recruitment Status: Completed
• First Posted: July 22, 2003
• Last Update Posted: September 24, 2012
• Sponsor: The Cleveland Clinic
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Joan Fox, The Cleveland Clinic

Tracking Information

• First Submitted Date: July 18, 2003
• First Posted Date: July 22, 2003
• Last Update Posted Date: September 24, 2012
• Study Start Date: April 2005
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2008)

• To evaluate the effects of Reiki on anxiety states using validated psychometric instruments. [ Time Frame: Each 30 minute session ]
• To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels [ Time Frame: Each 30 minute session ]
• To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma. [ Time Frame: throughout study ]

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: August 14, 2008): To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms [ Time Frame: Throughout study ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reiki/Energy Healing in Prostate Cancer
• Official Title: Effects of Energy Healing on Prostate Cancer
• Brief Summary: The purpose of this study is to determine whether Reiki energy healing affects anxiety and disease progression in patients with localized prostate cancer who are candidates for radical prostatectomy.
• Detailed Description: 120 newly diagnosed prostate cancer patients will be randomized to one of 3 groups: Reiki, another touch therapy, or guided imagery. Subjects in the Reiki and touch therapy groups have 8 sessions in the 4 weeks prior to their medical intervention. Those in the imagery group have one session prior to their medical intervention.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Behavioral: Reiki
  Energy therapy - 8 biweekly sessions of 30 minutes
  Other Names:

  • Energy Therapy
  • Touch Therapy
  • Energy Healing
• Behavioral: Pretend Reiki
  Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
  Other Name: Touch
• Behavioral: Rest / Guided Imagery
  4 weekly sessions of 30 supine rest listening to soft music. One session of Guided Imagery followed at visit 9. Listen to CDs twice a day 3 days prior to and 2 days following surgery (affect only post surgery outcomes)
  Other Name: Guided Imagery

Study Arms

• Experimental: Reiki
  Energy therapy
  Intervention: Behavioral: Reiki
• Sham Comparator: Pretend Reiki
  Intervention: Behavioral: Pretend Reiki
• Rest / Guided Imagery
  Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes
  Intervention: Behavioral: Rest / Guided Imagery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2009): 79
• Original Enrollment (submitted: June 23, 2005): 120
• Actual Study Completion Date: June 2010
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• Newly diagnosed with prostate cancer
• Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these

Exclusion criteria:

• Already involved in energy healing treatments
• Any patient whose medical intervention could not wait the 4-weeks for intervention for medical reasons
• Any patient who gets neo-adjuvant therapy or any herbal product that could affect PSA

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00065208
• Other Study ID Numbers: R21AT001120( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Joan Fox, The Cleveland Clinic
• Study Sponsor: The Cleveland Clinic
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Joan Fox, Ph.D.; The Cleveland Clinic

• PRS Account: The Cleveland Clinic
• Verification Date: September 2012